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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC
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QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC Back to Search Results
Lot Number 5233423
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the infusion set's tubing detached at the quick release and the patient noticed insulin out of the tubing.This issue occurred with a couple of sets.No further information available.
 
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Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 80/9 PCC
MDR Report Key8953470
Report Number3003442380-2019-01756
Device Sequence Number2399882
Product Code FPA
UDI-Device Identifier05705244006577
UDI-Public05705244006577
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date06/01/2021
Device Lot Number5233423
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/12/2019
Initial Report FDA Received Date09/02/2019
Patient Sequence Number1
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